BEUDAMED
    FDA Recall Terminated

    Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System

    Recall: Z-2348-2019 · Initiated March 30, 2019

    Recall

    Recall Number
    Z-2348-2019
    Event Number
    83357
    Firm
    Thoratec Corp.
    FEI Number
    2916596
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 30, 2019
    Terminated
    August 24, 2020
    Address
    6035 Stoneridge Dr, Pleasanton, CA, 94588-3270

    Description

    Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System

    Reason

    Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.

    Action

    On March 30, 2019 all consignees were hand delivered the "Urgent Medical Device Recall" letter. The recall letter stated the following: 1. Abbott is recalling 208 HeartMate 3 Outflow Graft units globally (87 within the US). An Abbott Representative will be contacting you within the coming weeks to identify the specific units that are impacted in your inventory and replace them. 2. In the interim, continued implants with the current HeartMate 3 Outflow Grafts can still be conducted with standard implant procedures by following the HeartMate 3 Instructions for Use. However, in addition to following the existing instruction of checking for blood leaks and bleeding at the Outflow Graft When the flow through the blood pump is satisfactory, we now recommend that adequate performance of the Screw Ring attachment to the pump be evaluated before the device is brought to the surgical field. If the Screw Ring does not function properly, the Outflow Graft should be replaced with a backup Outflow Graft. Patient Management Recommendations 3. For patients implanted with the HeartMate 3 Left Ventricular Assist System (LVAS), Abbott confirms there is no risk due to this issue. Patients should be managed per standard clinical practice. 4. Please complete the acknowledgement form included in this packet and return to Abbott. If you are a consignee of this letter within your organization, please notify all users of the device within your organization. 5. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. " Complete and submit the report Online: www.fda.gov/medwatch/report.htm " Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed from, or submit by fax to 1-800-FDA-0178. 6. If you have questions,

    Distribution

    Worldwide distribution. US nationwide, Australia, Austria, Brazil, Canada, Cayman Islands, Chile, Colombia, Egypt, France, Germany, Greece, Singapore, Iran, Italy, Kuwait, Lebanon, Romania, Switzerland, Thailand, United Kingdom.

    Quantity

    7200 left ventricular assist systems